Featured Articles

  1. Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication 7/22/2020

    Cure HHT, a foundation representing patients suffering from Hereditary Hemorrhagic Telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an Investigational New Drug (IND) application with the FDA.

  2. Parenteral Drug Manufacturing — Innovation Begins With A Problem 6/11/2020

    Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.

  3. Client Oriented Project Management 8/5/2020

    With the significant amount of outsourcing being done by the pharmaceutical industry, we believe project management has earned the right to be a critical factor in CDMO selection and deserves some exploration and understanding. Over our 26-year history and having successfully completed over 400 development projects, Pii has developed and refined project management operations to ensure outcomes are achieved and client expectations are exceeded. We have found that excellent project management has seven distinct features.

  4. Tech Transfer For Oral Products

    With the right CDMO, a proper tech transfer offers an opportunity to re-examine quality, process procedures, and supply chain issues, including provider partnerships.

  5. Drug Repurposing Advantages And Strategies

    Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.

  6. Meet Koshy George, Associate Director Of Manufacturing, Science And Technology

    Koshy George is a true Medicine Man. He knew as a young boy growing up in India that he wanted to make medicine.

  7. Optimizing Filling Technology To Minimize API Loss

    New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.

  8. Supply Chain Transformation, 503B And Reducing Drug Shortages 9/11/2020

    Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.

  9. Meet The Scientist — Sundeep Sethia, Ph.D.

    Many promising drug development candidates never advance beyond the preclinical stage because of bioavailability and solubility challenges. Dr. Sundeep Sethia has dedicated his life toward overcoming this initial hurdle in the drug development process.

  10. The Importance Of Analytical R&D To Sterile Fill/Finish

    Parenteral drug product development and production rely on the careful integration of supporting elements, with analytical support as key. Analytical support is required at all stages of the product’s life cycle, from early development to commercialization.